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Full-dose bivalirudin infusion after PCI tied to better outcomes vs. low dose in ACS
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Among patients with ACS who received an infusion of bivalirudin after PCI, those who had a full dose showed better outcomes than those who had a reduced dose, according to new data from the MATRIX trial.
As Cardiology Today’s Intervention previously reported, MATRIX was a 2x2 factorial trial in which patients with ACS undergoing PCI were assigned bivalirudin or heparin and transradial access or transfemoral access.
For the present analysis, researchers analyzed the 1,799 patients from the bivalirudin group who were assigned a bivalirudin infusion after PCI, comparing the 612 patients who received a full dose after PCI with the 1,068 patients who received a reduced dose after PCI. Dosage was at the discretion of the operator.
Full dose superior
The primary outcome of urgent target vessel revascularization, definite stent thrombosis or net adverse clinical events — defined as all-cause death, MI, stroke or major bleeding — at 30 days was lower in the full-dose group, whether analyzed by multivariable adjustment (rate ratio = 0.21; 95% CI, 0.12-0.35) or propensity-score adjustment (rate ratio = 0.16; 95% CI, 0.09-0.26), Giuseppe Gargiulo, MD, PhD, from the department of cardiology at Bern University Hospital, Switzerland, and colleagues wrote.
Among the other 30-day outcomes that were better in the full-dose bivalirudin group compared with the low-dose group and the heparin group included death/MI/stroke (P < .001), death/MI/stroke/major bleeding (P < .001), MI (P < .001), TVR (P = .007), definite stent thrombosis (P = .008), definite or probable stent thrombosis (P = .004) and major bleeding (P = .013), according to the researchers.
The results were consistent regardless of whether patients had STEMI or non-ST-segment elevation ACS, according to the researchers.
“Our findings altogether lend support to the use of a post-PCI full bivalirudin infusion regimen to further optimize outcomes in bivalirudin-treated ACS patients (which is in keeping with the updated U.S. Food and Drug Administration label of the product), due to the reduction of ischemic risk without compromising safety,” Gargiulo and colleagues wrote.
Interpret with caution
“In light of the post hoc nature of these comparisons, the multiplicity of analyses, and the selection of subgroups from subgroups, the findings must be interpreted with caution and considered as exploratory,” Cardiology Today’s Intervention Editorial Board Members Gilles Montalescot, MD, PhD, professor of cardiology and head of the cardiology department at Institut de Cardiologie, Pitié-Salpêtrière, Paris, and Dominick J. Angiolillo, MD, PhD, professor of medicine, medical director of the Cardiovascular Research Program and program director of the Interventional Cardiology Fellowship Program at the University Florida College of Medicine – Jacksonville, wrote in a related editorial. “Keeping these limitations in mind, it appears that the absence of effect of bivalirudin prolongation was the same in patients presenting with STEMI or non-ST-segment elevation ACS as well as the apparent superiority of the full dose over the low dose when bivalirudin was prolonged.” – by Erik Swain
Disclosures: The original MATRIX study was supported in part by grants from Terumo and The Medicines Company, but the present analysis was not. Gargiulo reports no relevant financial disclosures. Please see the full study for all other authors’ relevant financial disclosures. Angiolillo and Montalescot report they have financial ties with numerous pharmaceutical and device companies.
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